Donafenib and Toripalimab Combined With TACE in Patients With Unresectable Hepatocellular Carcinoma

March 4, 2024 updated by: Suzhou Zelgen Biopharmaceuticals Co.,Ltd

Dose Escalation Study Of Donafenib and Toripalimab Combined With TACE in Patients With Unresectable Hepatocellular Carcinoma

This study is the single-center, open-label phase I clinical trial to evaluate tolerability, safety and efficacy of Donafenib and JS001 in combination with TCAE in patients with Unresectable Hepatocellular Carcinoma.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

The phase I clinical trial is to determine the maximum tolerated dose (MTD) and dose limiting toxicity (DLT) of Donafenib in this regimen, and select an acceptable safe dose for the phase II clinical trial(RP2D).

Study Type

Interventional

Enrollment (Estimated)

18

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Hunan
      • Changsha, Hunan, China, 410006
        • Hunan Cancer Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age 18-75 (inclusive), male or female;
  • Diagnosis of Unresectable Hepatocellular Carcinoma confirmed clinically or histologically or cytologically according to the "Guidelines for diagnosis and treatment of primary liver cancer" (2019 Edition);
  • At least one measurable lesion (according to RECIST v1.1)
  • ECOG performance status score of 0 -1;
  • Life expectancy ≥ 12 weeks;
  • Fully understand this research and voluntarily sign the ICF.

Exclusion Criteria:

  • Diffuse liver cancer；
  • Refractory hepatic encephalopathy, refractory ascites, or hepatorenal syndrome；
  • Pregnancy or lactation；
  • Patients with extrahepatic diffusion；
  • Spontaneous tumor rupture；
  • Expected non-compliance.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Donafenib/JS001/TACE
Donafenib and JS001 Combined With TACE
Drug: Donafenib Tosilate Tablets
100mg Qd/150mg Qd/100mg Bid, po
Biological: Toripalimab Injection
240 mg, iv drip,q3w
Other Names:
  • JS001

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dose limiting toxicity(DLT)
Time Frame: 21 days after the first dose of JS001 and Donafenib, assessed up to 2 years
Dose limiting toxicity (DLT) is referred to grade 3 non-hematological toxicity or grade 4 hematological toxicity.
21 days after the first dose of JS001 and Donafenib, assessed up to 2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival (OS)
Time Frame: From the date of randomization until death due to any cause, assessed up to 2 years.
The Kaplan-Meier survival from the initiation date of first cycle until death from any cause or the last follow-up date.
From the date of randomization until death due to any cause, assessed up to 2 years.
Progression free survival (PFS)
Time Frame: From date of randomization until the date of objective disease progression or death, assessed up to 2 years.
The Kaplan-Meier survival from the initiation date of first cycle until the date of first documented progression or date of death
From date of randomization until the date of objective disease progression or death, assessed up to 2 years.
Duration of response (DOR)
Time Frame: From the date of first documented response (RECIST 1.1.) until the first date of documented progression or death in the absence of disease progression, assessed up to 2 years.
defined as the time between the first assessment of a tumor as PR or CR and the first assessment as PD or any cause of death
From the date of first documented response (RECIST 1.1.) until the first date of documented progression or death in the absence of disease progression, assessed up to 2 years.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Suzhou Zelgen Biopharmaceuticals Co.,Ltd

Investigators

  • Principal Investigator: Shanzhi Gu, MD, Hunan Cancer Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 8, 2021

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

October 21, 2020

First Submitted That Met QC Criteria

October 21, 2020

First Posted (Actual)

October 27, 2020

Study Record Updates

Last Update Posted (Actual)

March 6, 2024

Last Update Submitted That Met QC Criteria

March 4, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JS001D-C-103

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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